Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk… (NCT07402525) | Clinical Trial Compass
RecruitingNot Applicable
Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
China190 participantsStarted 2026-01-26
Plain-language summary
The goal of this clinical trial is to learn whether postoperative radiotherapy can delay disease recurrence in patients with early-stage oral squamous cell carcinoma who have high-risk factors. The main question it aims to answer is: Is the clinical outcome of early-stage tongue squamous cell carcinoma patients with risk factors after tumor enlargement resection receiving postoperative radiotherapy better than that of patients with simple follow-up observation? How is the safety? Researchers will compare the postoperative radiotherapy group and the simple follow-up observation group to see if there are differences between the two groups in terms of 3-year disease-free survival rate, 5-year disease-free survival rate, overall survival rate, toxicity events, and quality of life.
Participants of postoperative radiotherapy group will receive postoperative radiotherapy 6-8 weeks after surgery.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old and ≤ 70 years old, gender not limited;
✓. Newly treated patients (who have not undergone radiotherapy, chemotherapy, or targeted therapy before);
✓. Complete resection of the tumor with naked eye and no residual tumor observed in postoperative pathology;
✓. The lesion is limited to the anterior 2/3 of the tongue (active part of the tongue);
✓. Postoperative pathological diagnosis was squamous cell carcinoma of the tongue;
✓. According to AJCC 8th edition, the pathological TNM staging is T1-2N0M0;
✓. Having at least one risk factor: vascular cancer thrombus, nerve invasion, moderate or low differentiation;
✓. The general status score of the Eastern Cancer Collaboration Group (ECOG) is 0-2 points;
Exclusion criteria
✕. Patients who invade the oropharynx, mouth floor, cheeks, neck, and other organs;
What they're measuring
1
3-year DFS
Timeframe: 3 years
Trial details
NCT IDNCT07402525
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
✕. Have received chemotherapy or other anti-tumor drugs;
✕. Previously received radiation therapy for the head and neck area;
✕. Patients with active autoimmune diseases that require systemic treatment in the past;
✕. Pregnant or lactating women;
✕. Individuals with acute infections that are difficult to control;
✕. Patients with drug abuse, drug abuse, long-term alcoholism and AIDS;
✕. The subjects also have other known invasive malignant tumors (excluding those with no evidence of tumor recurrence through treatment and a duration of more than 2 years);